Month: July 2024

The ongoing fascination with emerging technologies and treatments in mental health care, particularly for conditions such Desert Storm Syndrome (DSS), has sparked a significant discussion about our priorities and the approach we take towards healing. The allure of novel therapies, such as MDMA-assisted treatment for PTSD, compels a deeper examination of whether our quest for […]

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Establishing a Quality Management System (QMS) is essential for medical device startups, not only for regulatory compliance but also for enhancing operational efficiency and product quality. In the U.S., QMS requirements for medical devices are specified under FDA 21 CFR Part 820, detailing necessary actions for developing and maintaining a compliant system. Globally, ISO 13485:2016 […]

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The Food and Drug Administration (FDA) has announced plans to broaden the scope of its Total Product Life Cycle (TAP) advisory program. Set to take effect in stages, the expansion will include radiological and ophthalmic medical devices starting from October this year, and orthopedic devices from January 1, 2025. The initiative aims to build upon […]

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Diabetes is a significant health concern in the United States, affecting approximately 15% of the adult population and resulting in over 100,000 deaths annually. Given the serious and pervasive nature of this condition, the development and evolution of medical devices aimed at diabetes management are increasingly critical. These devices, particularly continuous glucose monitors (CGMs), are […]

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The U.S. Food and Drug Administration (FDA) has intensified its scrutiny over the imports of plastic syringes from China due to concerns over their quality. Specifically, during November, the FDA highlighted issues potentially affecting these syringes, including the risk of leaks and breakages. Consequently, the agency advised healthcare providers to opt for syringes produced outside […]

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Unfortunately, the text you’ve provided seems to be an introduction or a fragment and it doesn’t contain enough content to summarize into 800 words. The paragraph offers a brief overview of the FDA’s new draft guidance on diversity action plans, indicating that this guidance was completely rewritten following new authority granted to the FDA by […]

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Alcon, a prominent player in eye care, has finalized its acquisition of glaucoma device maker Belkin Vision. Announced on a Monday, the purchase involves an upfront payment of $81 million with additional milestone payments potentially totaling up to $385 million. This deal grants Alcon ownership of innovative laser technology geared towards the treatment of open-angle […]

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Eli Lilly has successfully obtained FDA approval for its Alzheimer’s disease medication, Kisunla, a drug with similar therapeutic mechanisms to Eisai’s Alzheimer’s treatment but offers distinct dosing benefits that may attract patient preference. This approval follows unanimous support from an FDA advisory committee, recognizing Kisunla’s capability in decelerating cognitive decline outweighs its associated safety risks. […]

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On January 31, 2024, the FDA introduced the Final Rule for the new Quality Management System Regulation (QMSR), set to replace the existing Quality System Regulation (QSR) to align with ISO 13485:2016, which is the international standard for medical device quality management systems. This alignment aims to standardize good manufacturing practice (cGMP) requirements globally, a […]

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Merit Medical Systems recently announced the acquisition of the Esophyx Z+ acid reflux treatment from Endogastric Solutions for a sum of $105 million, showing its strategic commitment to expanding its portfolio in the gastrointestinal device market. Esophyx Z+, a minimally invasive device, targets gastroesophageal reflux disease (GERD), a condition affecting approximately 20% of the U.S. […]

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